The industry sees great promise in the continued adoption of disposable devices. Entirely disposable upstream processes that
can support large, commercial-scale production are becoming a reality, and now companies are focusing on cost-effective downstream
single-use innovations. Today, even the older, more conventionally built facilities are looking to modify their infrastructure
to support disposables for production. Over time, conventional processing equipment, in part or as integrated into overall
process trains and modules, will be replaced by disposable designs or established as hybrid production modules.
The future of innovation within disposables areas is likely to bring about an array of advances. These will be driven by
many important sub-trends that continue to shape this market. Industry experts from our BIC panel identified numerous such
- Building quality into single-use operations to further reduce regulatory activities and oversight
- Fixing disposable bioreactors that are creating inconsistent growth due to changes in resins, films, gamma irradiation, and
- The emergence of flexible and modular biomanufacturing facilities that reduce the need for expensive, stand-alone facilities
for every drug product
- Single-use devices facilitating large-scale bioproduction in developing regions
- Leachables and extractables standardization at clinical and commercial scale
- More new, scalable devices for downstream processing that get away from existing labor-intensive, costly technologies.
Although, as yet, there are few, if any non-rigid single-use devices (e.g., bioreactor bag liners) used in GMP applications,
this will likely change quickly as new products move through the development pipeline, into clinical-scale manufacturing,
and on to regulatory approval for commercial GMP production. Leachables and extractables will remain a concern, but as data
are developed and experience accumulates, the worries will diminish. The more vendors collaboratively work with customers,
the greater the likelihood that disposable, single-use products will deliver sooner on their promise to change bioprocessing
for the better.
Further, as regulators gain familiarity with the safety profiles and materials used in these devices, necessary approvals
for product manufacture will be facilitated. When this occurs, the market volume for single-use devices is likely to increase
ERIC S. LANGER is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing
firm in Rockville, MD, firstname.lastname@example.org
1. BioPlan Associates, 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (Rockville, MD, April 2013).
2. BioPlan Associates, BioPlan Associates' 2013 Biotechnology Industry Council Trends Analysis Study, (Rockville, MD, December 2012).